Ernexa Therapeutics Secures FDA Approval for Pre-IND Meeting, Advances Toward Clinical Trial for Ovarian Cancer Treatment

Ernexa Therapeutics participated in a virtual investor "What This Means" segment to discuss its successful Pre-IND meeting with the U.S. FDA and advancement toward a first-in-human trial for ovarian cancer. The FDA has aligned with Ernexa's development strategy for its lead cell therapy, ERNA-101, which will enable submission of an Investigational New Drug application and initiation of clinical testing in H2 2026. Manufacturing transfer is underway, accelerating operational readiness and positioning Ernexa to advance its synthetic, allogeneic induced mesenchymal stem cell therapies for ovarian cancer and autoimmune disease.